Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss (MICROS)

Comparison of Bone Microarchitecture Analysed by High Resolution Peripheral Microscanner (HR-pQCT) and Peripheral Microscanner (pQCT) in Pathologies With Bone Loss and/or Muscle Loss

The study aims to utilize medical devices, such as the Xtreme CT and XCT 3000, to assess bone and muscle microarchitecture for various pathologies. The devices provide crucial data on bone and muscle density, aiding in understanding fracture risks associated with conditions like rheumatoid arthritis and neurological disorders. Current methods like DXA scanning have limitations in predicting fracture risks accurately due to their inability to assess cortical and trabecular microstructure. The study emphasizes the importance of evaluating cortical porosity and trabecular volume loss, especially in conditions like post-menopausal osteoporosis and sarcopenia. Additionally, it explores the impact of neurological disorders, renal insufficiency, and endocrinopathies on bone health. Furthermore, the study aims to establish a control group to differentiate pathological changes from age-related variations. Expected outcomes include a comprehensive understanding of bone microarchitecture alterations across various pathologies and the potential to improve fracture risk estimation beyond conventional methods like DEXA scanning. Ultimately, the study anticipates facilitating better management strategies to reduce fracture risks associated with these conditions.

Study Overview

• Status: Recruiting
• Conditions: Bone Loss; Osteoporosis Risk
• Intervention / Treatment: Device: HR-pQCT; Device: pQCT; Device: DEXA

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hubert MAROTTE, PhD; Phone Number: +33 (0)477127643; Email: hubert.marotte@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU Saint Etienne
    • Principal Investigator: Hubert MAROTTE, PhD
    • Sub-Investigator: Adamah AMOUZOUGAN, MD
    • Contact: Hubert MAROTTE, PhD; Phone Number: +33 (0)477127649; Email: hubert.marotte@chu-st-etienne.fr
    • Contact: Florence Rancon; Phone Number: +33 (0)477829458; Email: florence.rancon@chu-st-etienne.fr
    • Sub-Investigator: Tierry THOMAS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For the patients:

Women or men treated at the Saint-Etienne University Hospital and presenting an osteoporotic risk with one of the following associated pathologies:

• Osteoporosis defined by: History of a documented brittle bone fracture
• Bone fragility: Patient with indication for bone densitometry but no history of fracture

• Inflammatory joint disease:

  • Rheumatoid arthritis
  • Spondyloarthritis
• Chronic kidney disease

• Endocrinopathies:

  • Primary hyperparathyroidism
  • Constitutional thinness
  • Anorexia nervosa
  • Obesity (BMI >30)
  • Sarcopenia
• Neuropathies - Parkinson's disease

For the controls:

Acute episode of spinal or radiculalgia (less than one month old) with corticosteroid treatment of less than 1 month Signature of written consent

Exclusion Criteria:

• No sign written consent

For the controls:

• Medications inducing bone loss:
• anti-aromasin or GnRH agonist for at least 6 months,
• corticosteroids (dose ≥ 5 mg/d for 6 months)
• anti-epileptic drugs: carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months)
• History of fracture due to bone fragility
• Taking bone-targeting medication (biphosphonate, teriparatide, strontium ranelate)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient group; Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis.	Device: HR-pQCT; Xtreme CT® device is a high resolution peripheral quantitative computed tomography (HR-pQCT) used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body. For the study, the device will be used to assess bone density and microarchitecture at the forearm and shin for a systemic effect. In rheumatoid arthritis, bone density and microarchitecture will also be measured at the metacarpophalangeal.; Device: pQCT; Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.; Device: DEXA; The Lunar Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck.
Experimental: Control group; Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis.	Device: HR-pQCT; Xtreme CT® device is a high resolution peripheral quantitative computed tomography (HR-pQCT) used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body. For the study, the device will be used to assess bone density and microarchitecture at the forearm and shin for a systemic effect. In rheumatoid arthritis, bone density and microarchitecture will also be measured at the metacarpophalangeal.; Device: pQCT; Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.; Device: DEXA; The Lunar Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total volumetric mineral density by HR-pQCT	Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies	Day 1
trabecular volumetric mineral density by HR-pQCT	Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.	Day 1
Cortical volumetric mineral density by HR-pQCT	Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.	Day 1
Describe number of trabeculae by HR-pQCT	Number of trabeculae (1/mm) as a function of pathologies.	Day 1
Trabecular thickness by HR-pQCT	Describe trabecular thickness (mm) as a function of pathologies.	Day 1
cortical thickness (mm) by HR-pQCT	Describe cortical thickness (mm) as a function of pathologies.	Day 1
trabecular separation by HR-pQCT	Describe trabecular separation (mm) as a function of pathologies.	Day 1
cortical porosity by HR-pQCT	Describe cortical porosity (%) as a function of pathologies.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total bone mineral content with pQCT	Total bone mineral content (mg)	Day 1
Total bone surface with pQCT	Total bone surface (mm2)	Day 1
Total bone density with pQCT	Total bone density (mg/mm3)	Day 1
Cortical and trabecular density with pQCT	Cortical and trabecular density (mg/mm3)	Day 1
bone resistance index with pQCT	bone resistance index (g2/mm)	Day 1
Bone density by DEXA	Parameter measured by DEXA is Bone Mineral Density (BMD, g/cm2).	Day 1
volumetric mineral density with HR-PQCT	Total volumetric mineral density (mg/ccm HA)	Day 1
Trabecular volumetric mineral density with HR-PQCT	Trabecular volumetric mineral density (mg/ccm HA)	Day 1
Cortical volumetric mineral density with HR-PQCT	Cortical volumetric mineral density (mg/ccm HA).	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hubert MAROTTE, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: osteoporosis; Bone fragility; Bone microarchitecture
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: 24CH080; ANSM (Other Identifier: 2025-A02921-48)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No